Trimetazidine Therapy in Hypertrophic Cardiomyopathy
A Phase 2b Randomised, Double Blind, Placebo-controlled Trial of Trimetazidine Therapy in Patients With Non-obstructive Hypertrophic Cardiomyopathy
1 other identifier
interventional
90
1 country
1
Brief Summary
Hypertrophic cardiomyopathy (HCM) is a common inherited heart condition that causes breathlessness, chest pain and fatigue. There are few treatments available. The investigators have recently shown that a drug called perhexiline reduced symptoms and improved exercise capacity in patients with HCM. This change appears to be driven by alterations in myocardial energy metabolism. The aim of this trial is to test a similar drug, trimetazidine, in a group of symptomatic patients with non-obstructive HCM. HYPOTHESIS: trimetazidine will improve symptoms, peak oxygen consumption, cardiac function and arrhythmia burden in medically refractory symptomatic patients with non-obstructive HCM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 27, 2012
CompletedFirst Posted
Study publicly available on registry
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedFebruary 28, 2013
August 1, 2011
2 years
September 27, 2012
February 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peak oxygen consumption
3 months
Secondary Outcomes (5)
Left ventricular function
3 months
Symptom status
3 months
Arrhythmia
3 months
Cardiac biomarkers
3 months
Exercise capacity
3 months
Study Arms (2)
Trimetazidine
ACTIVE COMPARATORPlacebo capsule
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Non-obstructive hypertrophic cardiomyopathy (gradient \<30 mmHg at rest)
- NYHA (New York Heart Association) Class ≥ 2
- Peak VO2 (maximal oxygen consumption) ≤80% predicted for age and gender
- Heart rate \< 90/minute at rest
You may not qualify if:
- Diabetes Mellitus
- Abnormal renal function (GFR\<60ml/min) or hepatic impairment
- Female who is pregnant, lactating or planning pregnancy during the course of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University College, Londonlead
- British Heart Foundationcollaborator
Study Sites (1)
The Heart Hospital, UCLH
London, W1G 8PH, United Kingdom
Related Publications (1)
Coats CJ, Pavlou M, Watkinson OT, Protonotarios A, Moss L, Hyland R, Rantell K, Pantazis AA, Tome M, McKenna WJ, Frenneaux MP, Omar R, Elliott PM. Effect of Trimetazidine Dihydrochloride Therapy on Exercise Capacity in Patients With Nonobstructive Hypertrophic Cardiomyopathy: A Randomized Clinical Trial. JAMA Cardiol. 2019 Mar 1;4(3):230-235. doi: 10.1001/jamacardio.2018.4847.
PMID: 30725091DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Perry M Elliott, MBBS MD
University College, London
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2012
First Posted
October 1, 2012
Study Start
April 1, 2012
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
February 28, 2013
Record last verified: 2011-08